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Global Regulatory Requirements for Medical Devices
Mälardalen University, School of Sustainable Development of Society and Technology.
2008 (English)Independent thesis Basic level (professional degree), 20 points / 30 hpStudent thesis
Abstract [en]

Medical devices are becoming more important in the health care sector. One of the major issues for companies developing and producing medical devices is to be updated on the regulatory requirements and implement them in the process. This thesis examines the regulatory requirements for medical devices in Argentina, Australia, Brazil, Canada, India, Japan, Mexico, Russia, South Korea and Taiwan and compares them with the requirements in the European Union.

The conclusion of this thesis is that most countries have similar requirements for registration of medical devices and are striving to harmonize with the GHTF guidelines. A company goes far by following the requirements in EU, USA or the GHTF guidelines.

Place, publisher, year, edition, pages
Akademin för hållbar samhälls- och teknikutveckling , 2008. , 51 p.
Keyword [en]
medical devices, quality, regulations, classification, risk management
Keyword [sv]
medicinsk teknik, kvalitet, regelverk, klassificering, riskhantering
National Category
Medical Laboratory and Measurements Technologies
URN: urn:nbn:se:mdh:diva-700OAI: diva2:121327
2008-05-14, K338, Verktyget, Smedjegatan 37, Eskilstuna, 09:00
Available from: 2008-06-05 Created: 2008-06-05

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